UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063223 |
|---|---|
| Receipt number | R000072364 |
| Scientific Title | Clinical study for the effect of improving posture, pain, fatigue, sleep, and autonomic nervous system, intestinal environment by combination of chiropractic care, dietary supplement, exercise, and bedding in healthy Japanese: a pre-post comparison study |
| Date of disclosure of the study information | 2026/10/08 |
| Last modified on | 2026/10/08 17:21:03 |
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Basic information
Public title
Clinical study for the effect of improving posture, pain, fatigue, sleep, and autonomic nervous system, intestinal environment by combination of chiropractic care, dietary supplement, exercise, and bedding in healthy Japanese: a pre-post comparison study
Acronym
Clinical study for the effect of improving posture, pain, fatigue, sleep, and autonomic nervous system, intestinal environment by combination of chiropractic care, dietary supplement, exercise, and bedding in healthy Japanese: a pre-post comparison study
Scientific Title
Clinical study for the effect of improving posture, pain, fatigue, sleep, and autonomic nervous system, intestinal environment by combination of chiropractic care, dietary supplement, exercise, and bedding in healthy Japanese: a pre-post comparison study
Scientific Title:Acronym
Clinical study for the effect of improving posture, pain, fatigue, sleep, and autonomic nervous system, intestinal environment by combination of chiropractic care, dietary supplement, exercise, and bedding in healthy Japanese
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of improving physical function by combination of chiropractic care, dietary supplement, exercise, and bedding.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Posture, pain, fatigue, autonomic nervous system
Key secondary outcomes
1. Sleep, intestinal environment, blood pressure
2. Incidence of adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food | Device,equipment | Behavior,custom |
| Maneuver |
Interventions/Control_1
<Duration>
Seven weeks
<Test product>
Chiropractic care (once a week) + consumption of the test food (every day, NANO CALFAMILY PLUS / CHONDRO MATE KARYU / HEALTH RESVERA / EUGLERA) + mattress (every day) + exercise {every day, BODY CONTROL BAND (BCB) / Physical Activity (PA)}
<Administration>
Test food: Consume NANO CALFAMILY PLUS (one packet per day), CHONDRO MATE KARYU (one packet per day), HEALTH RESVERA (one tablet per day), and EUGLERA (three tablets per day) with water
*The daily dose should be consumed within the same day. If a dose is missed, it should be consumed as soon as remembered.
Mattress: Invention of using mattress
Exercise: Invention of BCB and PA
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Japanese
2. Women
3. Individuals aged between 40 and 60
4. Healthy individuals
5. Individuals who have not undergone chiropractic care (for at least one year)
6. Individuals who are healthy adults with no significant past or current medical history and who have subjective symptoms (chief complaints) related to pain, fatigue, or sleep on daily
7. Individuals who have received an explanation of the study, and understand its content, and agree with its purpose, prior to participating in this study and who are able to obtain informed consent from the study participants based on their free will
Key exclusion criteria
1. Individuals who are receiving treatment for malignant tumors, heart failure, or myocardial infarction
2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator
3. Individuals who are currently undergoing treatment for or have a history of any of the following chronic diseases:
cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, stroke disorder, lower extremity arterial disease, dyslipidemia, hypertension, neoplastic, hemorrhagic, infectious disease, amyotrophy disease, heart disease, disc herniation, ossification of the posterior longitudinal ligament, spondylosis deformans, spinal stenosis, osteoporosis, atlantoaxial subluxation, unstable spine, scoliosis, spina bifida, spondylolisthesis, or any other chronic diseases
4. Individuals who are allergic to medications or foods related to the test food
5. Individuals who have lactose intolerance
6. Individuals who have hereditary fructose intolerance
7. Individuals who have fructose malabsorption
8. Individuals who are pregnant, lactating, or planning pregnancy during this study
9. Individuals who suffer from COVID-19
10. Individuals who have participated in other clinical studies within 28 days before informed consent, or plan to participate in another study during this study
11. Individuals who are smokers
12. Individuals who are deemed unsuitable for participation in this study by the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Uto |
Organization
national university corporation Tokushima University
Division name
Graduate School of Technology, Industrial and Social Science, Tokushima University
Zip code
770-8506
Address
2-1, Minamijosanjima-cho, Tokushima city, Tokushima, Japan
TEL
088-656-7514
uto.yoshihiro@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Mika |
| Middle name | |
| Last name | Seki |
Organization
Cykinso, inc.
Division name
BtoB Division
Zip code
151-0053
Address
2F Okada Bldg., 1-36-1, Yoyogi, Shibuya-ku, Tokyo, Japan
TEL
03-6682-9973
Homepage URL
mykinsoresearch_mq05@cykinso.co.jp
Sponsor or person
Institute
national university corporation Tokushima University
Institute
Department
Personal name
Funding Source
Organization
national university corporation Tokushima University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nihontyokuhan Souhonsya Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
さくら総合病院 (愛知県)
Sakura General Hospital (Aichi, Japan)
株式会社サイキンソー (東京都)
Cykinso, inc. (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2026 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 08 | Day |
Last modified on
| 2026 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072364
